Investigating Dyadic Expectations About ARF Survivorship (IDEAS)
- Conditions
- Acute Respiratory FailureMental Health IssueCaregiving Stress
- Interventions
- Other: Dyadic expectations about the ARF survivor's perceived health 6 months after hospital dischargeOther: Self-efficacyOther: Concordant expectations/shared appraisal of ARF survivor's health 6 months after hospital discharge
- Registration Number
- NCT06401239
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
The purpose of this observational study is to understand how adults who survive acute respiratory failure (ARF) and the people (usually family) who support ARF survivors after returning home think about the first 6 months of recovery. The study aims to find out if expectations about the recovery process after ARF are associated with mental health symptoms in both survivors and the survivor's care partners. Study participants will complete 3 surveys over 6 months. These surveys ask questions about participants' future expectations, feelings, and mood. Surveys can be completed online, over the phone, or on paper.
- Detailed Description
The overarching objectives of the Investigating Dyadic Expectations about ARF Survivorship (IDEAS) cohort study are to learn how expectations about ARF survivorship are related to dyadic mental health symptoms and dyadic coping. Specifically, the study aims are:
* Aim 1: To determine whether health expectations and self-efficacy after acute respiratory failure (ARF) are associated with mental health outcomes in survivor-care partner dyads.
* Aim 2: To assess whether concordant expectations within survivor-care partner dyads are associated with better dyadic coping (primary outcome) and exploratory secondary outcomes.
The term dyadic coping refers to the ways two people interact as the pair manage illness-related stressors. Concordant expectations within dyads, also called shared appraisal, refers to both members of a dyad being "on the same page", and is hypothesized to lead to better dyadic coping behaviors.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 235
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≥18 years old
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Meets study definition of ARF:
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The study defines ARF as meeting 1 of the following 3:
- Mechanical ventilation via an endotracheal tube ≥24 consecutive hours OR
- Non-invasive ventilation (CPAP, BiPAP) ≥24 consecutive hours that is not for obstructive sleep apnea or other stable use OR
- High flow nasal cannula with fraction of inspired oxygen (FIO2)≥.5 and flow rate ≥ litres per minute (LPM) for ≥24 consecutive hours.
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Occasional rest periods of ≤1 hour are not deducted from the calculation of consecutive hours. Patients who are intubated for mental status or airway obstruction are not eligible unless they have simultaneous ARF.
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Survival to hospital discharge to home
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Speaks or reads English or Spanish
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Identifies an adult who is expected to act as a primary care partner for at least the next 6 months.
Patient
- Pre-existing cognitive impairment (IQ-CODE >3.6)
- Residing in a medical institution at hospital discharge
- Receiving hospice care or life expectancy <6 months
- Homelessness or recent history of psychosis
Care Partner Inclusion Criteria:
- ≥18 years old
- Speaks or reads English or Spanish
Care Partner Exclusion Criteria:
- Pre-existing cognitive impairment (IQ-CODE >3.6)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ARF Survivor-Care Partner Dyads Dyadic expectations about the ARF survivor's perceived health 6 months after hospital discharge The study will recruit 235 dyads of adult ARF survivors and care partners. The term "care partner" refers to an individual (e.g. family member or friend) that supports the survivor at home. ARF Survivor-Care Partner Dyads Concordant expectations/shared appraisal of ARF survivor's health 6 months after hospital discharge The study will recruit 235 dyads of adult ARF survivors and care partners. The term "care partner" refers to an individual (e.g. family member or friend) that supports the survivor at home. ARF Survivor-Care Partner Dyads Self-efficacy The study will recruit 235 dyads of adult ARF survivors and care partners. The term "care partner" refers to an individual (e.g. family member or friend) that supports the survivor at home.
- Primary Outcome Measures
Name Time Method Symptoms of Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS) 3 and 6 months after ARF survivor's ICU discharge Symptoms of anxiety and depression in both members of enrolled dyads will be assessed at 3- and 6-month follow-up assessments using the HADS. The HADS has 14 items. Scores for the anxiety and depression subscales range from 0 - 21 with scores ≥8 reflective of clinically significant symptoms.
Dyadic Coping as Assessed by the Dyadic Coping Inventory (DCI) 3 and 6 months after ARF survivor's ICU discharge Dyadic coping will be assessed at 3- and 6-month assessments using the Dyadic Coping Inventory (DCI).The DCI contains 37 items that will be answered by both dyad members. Items are rated on a 5-point scale ranging from 1 ("Very rarely") to 5 ("Very often") and the total DCI score is the sum of items 1 through 35 after reverse coding negatively keyed items. There are established cut-off scores to evaluate dyadic coping as follows: DCI total score \< 111 reflects below average dyadic coping, DCI between 111-145 reflects normal dyadic coping, and DCI total score \> 145 reflects above average dyadic coping.
- Secondary Outcome Measures
Name Time Method Health-related Quality of Life as Measured by the European Quality of Life 5-Domain 5-level Questionnaire (EQ-5D-5L) 3 and 6 months after ARF survivor's hospital discharge The Health-related Quality of Life of the ARF survivor will be measured by the EQ-5D-5L. The EQ-5D-5L is made up of 6 items addressing mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and self-rated health. Index values will be calculated for the first 5 dimentions and converted to a US-based index value with negative values indicating states worse than death and 1.0 indicating perfect health. Self-rated health is assessed on a 0 - 100 scale with higher values indicating better perceived health. Population norms are available.
Social Isolation as Measured by Social Isolation Score 3 and 6 months after ARF survivor's hospital discharge Social isolation experienced by both members of the enrolled dyad will be measured by a social isolation score developed by Pohl and colleagues for the National Health and Aging Trends Study (NHATS). The score is derived from responses to 5 questions and ranges from 0 to 6 with high scores indicating greater isolation.
Symptoms of Post Traumatic Stress as Measured by the Impact of Events Scale-Revised (IES-R) 3 and 6 months after ARF survivor's hospital discharge Symptoms of Post Traumatic Stress in both members of enrolled dyads will be measured by the IES-R. The IES-R has 22-items, a total raw score range of 0-88, and subscales for Intrusion, Avoidance, and Hyperarousal. Higher scores indicate more symptoms of post-traumatic stress.
Financial Toxicity as Assessed by Qualitative Questions 3 and 6 months after ARF survivor's hospital discharge Financial Toxicity will be assessed by asking both members of the dyad whether the dyad have experienced 12 indicators of financial hardship since the index hospitalization. This list of indicators has previously been used in two peer-reviewed prospective cohort studies of people who survived hospitalization for COVID-19.
Trial Locations
- Locations (1)
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States